Tray, Start/Stop (Including Contents), Dialysis
The Dialysis Start/Stop Tray (Including Contents) is a pre-assembled procedural kit containing the supplies necessary to initiate and conclude a hemodialysis treatment session. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls. The product code is FKG, regulated under 21 CFR 876.5820 in the Gastroenterology and Urology specialty.
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Basic Information
- Product Code
- FKG
- Device Class
- FDA class 1
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K925469 | JJ SKINNER CAREKITS(TM) DIALYSIS ON/OFF KIT | May 03, 1995 | Substantially Equivalent | J.J. Skinner, Inc. |
| K871630 | KITS AND TRAYS FOR DIALYSIS USE | May 26, 1987 | Substantially Equivalent | Dove Medical Supplies |
| K833780 | CAPD PREP KIT | Feb 09, 1984 | Substantially Equivalent | Professional Dialysis Products |
| K802361 | DIALYIS START CARE KIT | Jan 16, 1981 | Substantially Equivalent | Med-Pak Corp. |
| K792207 | PERIDIAL PERITONEAL DIALYSIS TRAY | Dec 10, 1979 | Substantially Equivalent | Cutter Laboratories, Inc. |
| K790353 | ACUTE RENAL DIALYSIS TRAY | Apr 20, 1979 | Substantially Equivalent | Argon Medical Corp. |
FEI Numbers
This FDA classification entry is associated with 27 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 27 registration numbers. Click on an entry to view related FDA registrations.